Anterior Cruciate Ligament ReconstructionNCT01588977
Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction
An observational study of Anterior Cruciate Ligament Reconstruction and Subchondral Microfractures of Tibia, run by Hospital Ambroise Paré Paris at 3 sites in France.
Trial summary
The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction, Subchondral Microfractures of Tibia
- How many people
- 43 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2012to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear
Who may be able to join
- arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear
Who cannot join
- previous reconstruction of ACL
- associated lesions (meniscal tear, other ligament...)
- Refusal consent
Trial locations and contacts
3 sites in 1 country.
France3 sites
Ambroise Paré Hospital
Boulogne-Billancourt, 92104
Hôtel-Dieu CHU Nantes
Nantes, 44093
Polyclinique de L'Europe
Saint-Nazaire, 44600
About this study
Official title: Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain
The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All-Inside TightRope technique | Not described | |
| ACL reconstruction with TLS system | Not described | |
| Hamstring Tendon Graft Reconstruction of the ACL | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subchondral microfracture of tibia on MRI
Measured: 2 days after surgery
Secondary outcomes (1)
Pain on Visual Analogue Scale
Measured: During two days after surgery, twice a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588977
- Sponsor's protocol ID
- APR042012
- Status last verified
- Aug 2016
- First submitted
- 27 Apr 2012
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain
- ClinicalTrials.gov ID
- NCT01588977
- Acronym / sponsor ID
- APR042012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| All-Inside TightRope technique | – | – |
| ACL reconstruction with TLS system | – | – |
| Hamstring Tendon Graft Reconstruction of the ACL | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear
Key inclusion criteria (1 listed)
- arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear
Key exclusion criteria (3 listed)
- previous reconstruction of ACL
- associated lesions (meniscal tear, other ligament...)
- Refusal consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subchondral microfracture of tibia on MRI
Time frame: 2 days after surgery
1 secondary outcome
Pain on Visual Analogue Scale
Time frame: During two days after surgery, twice a day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Reconstruction and Subchondral Microfractures of Tibia, run by Hospital Ambroise Paré Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subchondral microfracture of tibia on MRI (time frame: 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.